Cleared Traditional

FTK FECAL TRANSPORT KIT (K890134) - FDA 510(k) Clearance

Class I Microbiology device.

K890134 · Evergreen Scientific, Inc. · Microbiology device
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Apr 1989
Decision
98d
Days
Class 1
Risk

K890134 is an FDA 510(k) clearance for the FTK FECAL TRANSPORT KIT. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Evergreen Scientific, Inc. (Los Angeles, US). The FDA issued a Cleared decision on April 21, 1989 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Evergreen Scientific, Inc. devices

Submission Details

510(k) Number K890134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1989
Decision Date April 21, 1989
Days to Decision 98 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 102d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LIO Device, Specimen Collection

All 62
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